Composition
1 tab .:
rebamipide 100 mg.
Excipients: mannitol - 35.7 mg, croscarmellose sodium - 14 mg, pregelatinized starch - 80.7 mg, sodium lauryl sulfate - 2 mg, citric acid - 2.3 mg, purified talc - 3.1 mg, magnesium stearate - 2.2 mg.
The composition of the film shell: hypromellose - 2.77 mg, purified talc - 0.57 mg, titanium dioxide - 1.11 mg, propylene glycol - 0.55 mg.
Pharmachologic effect
Clinico-pharmacological group: Gastroprotector
Pharmaco-therapeutic group: Gastroprotective agent
pharmachologic effect
Rebamipide increases the content of prostaglandin E2 (PGE2) in the gastric mucosa and increases the content of PGE2 and GI2 in the contents of the gastric juice. It has a cytoprotective effect on the gastric mucosa with the damaging effects of ethanol, acids and alkalis, acetylsalicylic acid. Promotes the activation of enzymes that accelerate the biosynthesis of high molecular weight glycoproteins, and increases the content of mucus on the surface of the stomach wall. It improves the blood supply to the gastric mucosa, activates its barrier function, activates alkaline secretion of the stomach, enhances the proliferation and metabolism of epithelial cells of the stomach, clears the mucosa from hydroxyl radicals and suppresses superoxides produced by polymorphonuclear leukocytes and neutrophils in the presence of Helicobacter pylori and protects. has a gastroprotective effect when exposed to the mucous NSAIDs.
Pharmacokinetics
Suction and distribution
After taking a dose of 100 mg Cmax is reached in approximately 2 hours and amounts to 340 ng / ml. Repeated doses of the drug do not lead to its cumulation in the body.
In vitro experiments showed that from 98.4% to 98.6% of the drug is bound by plasma proteins.
Metabolism and excretion
T1 / 2 is approximately 1.0 hours. Approximately 10% of the drug is excreted by the kidneys, mostly unchanged. When taken in a dose of 600 mg, it is possible to isolate traces of the hydroxylated metabolite.
Indications
- stomach ulcer;
- chronic gastritis with increased acid-forming function of the stomach in the acute phase, erosive gastritis;
- prevention of damage to the mucous membrane in the background of receiving NSAIDs;
Can be used in combination therapy.
Contraindications
- individual intolerance to ribamipid or other components of the drug;
- pregnancy;
- lactation period;
- age up to 18 years.
Side effects
On the part of the digestive system: constipation, flatulence, diarrhea, nausea, vomiting, pain in the abdomen, a violation of taste, heartburn.
On the part of the liver: signs of liver dysfunction, increased serum ALT and ACT.
From the hemopoietic system: leukopenia, granulocytopenia.
Other: irregular menstruation.
Interaction
With the use of rebamipide as part of traditional treatment regimens for patients with Helicobacter pylori infection, the effectiveness of eradication therapy increases significantly.
Reactions interaction with other drugs have not been studied.
How to take, the course of administration and dosage
Inside, on 1 tablet 3 times / days, washing down with a small amount of liquid. The course of treatment is 2-4 weeks, if necessary, may be extended to 8 weeks.
The drug does not have the peculiarities of the action at the first dose or when it is canceled.
When you skip taking one dose, you must take the next dose of the drug at the scheduled time, you should not take a double dose of the drug.
Overdose
Symptoms of an overdose with rebamipide have not been described, until today there has been no information about cases of deliberate overdose. Nausea, vomiting, abdominal pain, diarrhea or constipation, headache are possible.
Treatment: the specific antidote is unknown. In case of overdose, wash the stomach and carry out symptomatic therapy.
Special instructions
The safety of using rebamipide during pregnancy has not been proven. Do not use during pregnancy.
Since rebamipide is excreted in breast milk, breastfeeding should be discontinued or the question of artificial feeding of the child should be decided if the appointment of the mother of rebamipide is necessary during breastfeeding.
Use in children
Contraindicated in children under 18 years.
Use in elderly patients
At the first appointment of rebamipida patients with advanced age due to the possibility of increased sensitivity to the drug.
Influence on ability to drive vehicles and mechanisms
The effect of the drug on the speed of psychomotor reactions and / or the ability to drive vehicles or mechanisms has not been studied. In the case of the drug should be careful to drive a car and other activities that require high concentration of attention.
Release form
Tablets, film coated white or almost white, round, biconvex.
Storage conditions
The drug should be stored out of the reach of children, dry, protected from light, at a temperature not higher than 25 ° C.
Shelf life
2 years.
Active substance
Rebamipide
Manufacturer
McLeodz Pharmaceuticals, Czech Republic
Pharmacy sales terms
Over the counter
